U.S. patent number 8,118,738 [Application Number 11/899,522] was granted by the patent office on 2012-02-21 for vaginal speculum including collapsible and expandable frame.
Invention is credited to Daniel Larkin.
United States Patent |
8,118,738 |
Larkin |
February 21, 2012 |
Vaginal speculum including collapsible and expandable frame
Abstract
A vaginal speculum includes a frame and a first handle assembly
pivotally mounted to the frame. The frame defines an opening
between a first blade that is attachable to the frame and a second
blade that is attachable to the frame opposite of the first blade,
and a hinge assembly configured to flex the frame to selectively
change a size of the opening. The first handle assembly includes a
lever portion and a blade portion coupled to the lever portion. The
blades have a proximal end attachable to the blade portion and a
distal end portion spaced from the proximal end. When in a first
collapsed insertion state, the hinge assembly collapses the frame
and the first blade contacts the second blade. When in a second
deployed state the hinge assembly expands the frame and the first
blade is spaced apart from the second blade.
Inventors: |
Larkin; Daniel (St. Paul,
MN) |
Family
ID: |
40432618 |
Appl.
No.: |
11/899,522 |
Filed: |
September 6, 2007 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20090069634 A1 |
Mar 12, 2009 |
|
Current U.S.
Class: |
600/222 |
Current CPC
Class: |
A61B
1/32 (20130101); A61B 17/0206 (20130101); A61B
1/303 (20130101); A61B 1/0615 (20130101); A61B
1/0669 (20130101); A61B 17/42 (20130101); A61B
2017/00477 (20130101); A61B 17/3431 (20130101); A61B
17/0293 (20130101); A61B 17/3439 (20130101); A61B
2090/309 (20160201); A61B 46/10 (20160201); A61B
2017/00862 (20130101); A61B 2017/00907 (20130101) |
Current International
Class: |
A61B
1/32 (20060101) |
Field of
Search: |
;600/206,220-222,233 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Woodall; Nicholas
Attorney, Agent or Firm: Dicke, Billig & Czaja, PLLC
Claims
What is claimed is:
1. A vaginal speculum comprising: a frame that defines a proximal
side and a distal side and an opening within the frame between a
first blade that is attachable to the frame and a second blade that
is attachable to the frame opposite of the first blade, the frame
including a hinge assembly configured to flex the frame to
selectively change a size of the opening; and a first handle
assembly including a lever portion and a blade portion coupled to
the lever portion, the first handle assembly pivotally mounted to
the frame such that the lever portion extends from the proximal
side of the frame and the blade portion extends from the distal
side of the frame, each of the opposing first and second blades
having a proximal end configured for attachment to the blade
portion of the handle assembly and a distal end portion spaced from
the proximal end; wherein in a first collapsed insertion state the
hinge assembly collapses the frame and the first blade contacts the
second blade, and in a second deployed state the hinge assembly
expands the frame and the first blade is spaced apart from the
second blade; and wherein the blade portion of the first handle
assembly comprises a socket head that is configured to releasably
couple with a socket formed in the proximal end of the first
blade.
2. The vaginal speculum of claim 1, wherein the frame comprises: a
first arcuate segment including a first end and a separate second
end, the first blade attachable to the first arcuate segment; a
second arcuate segment including a first end and a separate second
end, the second blade attachable to the second arcuate segment; a
first hinge coupled between the first ends of the first and second
arcuate segments; and a second hinge coupled between the second
ends of the first and second arcuate segments.
3. The vaginal speculum of claim 2, wherein the first and second
arcuate segments each comprise: a flexible tubular housing; and a
coiled spring disposed within the housing, the coiled spring
extending between the first and second ends of a respective one of
the arcuate segments.
4. The vaginal speculum of claim 3, wherein each of the first and
second hinges include a spring-loaded clip comprising: a base
defining a slot, a spring inserted into the slot, and a follower
including first and second opposing ends, the first end of the
follower coupled to the spring and configured to slide into the
slot; wherein the base is coupled to one of the first and second
arcuate segments, and the second end of the follower is coupled to
an other of the first and second arcuate segments, such that the
follower is compressible into the slot of the base when the frame
is in the second deployed state.
5. The vaginal speculum of claim 2, wherein the first and second
arcuate segments each comprise: a rigid housing including a base, a
first tubular leg extending from the base, and a second tubular leg
extending from the base separated from the first tubular leg; and a
first coiled spring disposed within one of the first tubular legs
and a second coiled spring disposed within one of the second
tubular legs; wherein the first hinge comprises the first tubular
leg of the first arcuate segment inserted within the first tubular
leg of the second arcuate segment in a manner that contains the
first coiled spring, and the second hinge comprises the second
tubular leg of the first arcuate segment is insertable within the
second tubular leg of the second arcuate segment in a manner that
contains the second coiled spring.
6. The vaginal speculum of claim 2, wherein the first and second
arcuate segments each comprise: a rigid semi-circular housing;
wherein the first hinge comprises a leaf spring coupled between the
first ends of the first and second arcuate segments, and the second
hinge comprises a separate leaf spring coupled between the second
ends of the first and second arcuate segments.
7. The vaginal speculum of claim 2, further comprising: a frame
retention mechanism including a first flange coupled to the first
arcuate segment, a second flange coupled to the second arcuate
segment, and means coupled between the first and second flanges to
maintain the first arcuate segment in a position relative to the
second arcuate segment.
8. The vaginal speculum of claim 1, further comprising: a second
handle assembly mounted to the frame opposite of the first handle
assembly, the second handle assembly including a second lever
portion and a second blade portion coupled to the second lever
portion, the second lever portion extending away from the proximal
side of the frame and the second blade portion extending from the
distal side of the frame, the first blade removably attached to the
first blade portion and the second blade removably attached to the
second blade portion; wherein when the opposing first and second
blades are inserted into a vaginal introitus, movement of the first
lever portion moves the distal end portion of the first blade apart
from the distal end portion of the second blade to diverge and
support apposed walls of the vagina without increasing a distance
between the proximal ends of the opposing first and second
blades.
9. The vaginal speculum of claim 8, wherein the second handle
assembly is pivotally mounted to the frame and movement of the
first and second lever portions moves a respective distal end
portion of the opposing first and second blades one apart from an
other to diverge and support apposed walls of the vagina without
increasing a distance between the proximal ends of the opposing
first and second blades.
10. The vaginal speculum of claim 1, further comprising: at least
one lip coupled to and extending from the distal side of the frame,
the at least one lip configured to appose the patient when the
opposing first and second blades are inserted into a vaginal
canal.
11. The vaginal speculum of claim 1, further comprising: a lateral
dilator insertable into the opening, the lateral dilator
comprising: a collar including a collar wall configured to
removably couple with the frame; and at least one blade extending
from the collar and including a dilator handle assembly mounted to
the collar that is configured to move distal end portions of the
lateral blades.
12. The vaginal speculum of claim 11, wherein the at least one
blade extending from the collar is configured to transmit light
therethrough.
13. A vaginal speculum assembly comprising: a frame including: a
first segment including a first end and a separate second end, a
second segment including a first end and a separate second end,
means coupled between respective first ends of the first and second
segments and respective second ends of the first and second
segments to flex the frame; a first speculum blade attachable to
the first segment and a second speculum blade attachable to the
second segment; a lateral dilator configured for insertion through
an opening defined by the frame, the lateral dilator coupleable to
the frame and including at least one blade having a distal end that
is movable; and wherein the means coupled between respective first
ends of the first and second segments and respective second ends of
the first and second segments to flex the frame comprises a first
spring coupled between respective first ends of the first and
second segments and a second spring coupled between respective
second ends of the first and second segments.
14. A vaginal speculum comprising: a frame that defines a proximal
side and a distal side and an opening within the frame between a
first blade that is attachable to the frame and a second blade that
is attachable to the frame opposite of the first blade, the frame
including a hinge assembly configured to flex the frame to
selectively change a size of the opening; and a first handle
assembly including a lever portion and a blade portion coupled to
the lever portion, the first handle assembly pivotally mounted to
the frame such that the lever portion extends from the proximal
side of the frame and the blade portion extends from the distal
side of the frame, each of the opposing first and second blades
having a proximal end configured for attachment to the blade
portion of the handle assembly and a distal end portion spaced from
the proximal end; wherein in a first collapsed insertion state the
hinge assembly collapses the frame and the first blade contacts the
second blade, and in a second deployed state the hinge assembly
expands the frame and the first blade is spaced apart from the
second blade; wherein the frame comprises: a first arcuate segment
including a first end and a separate second end, the first blade
attachable to the first arcuate segment; a second arcuate segment
including a first end and a separate second end, the second blade
attachable to the second arcuate segment; a first hinge coupled
between the first ends of the first and second arcuate segments;
and a second hinge coupled between the second ends of the first and
second arcuate segments; and wherein the first and second arcuate
segments each comprise: a rigid semi-circular housing; wherein the
first hinge comprises a leaf spring coupled between the first ends
of the first and second arcuate segments, and the second hinge
comprises a separate leaf spring coupled between the second ends of
the first and second arcuate segments.
15. A vaginal speculum comprising: a frame that defines a proximal
side and a distal side and an opening within the frame between a
first blade that is attachable to the frame and a second blade that
is attachable to the frame opposite of the first blade, the frame
including a hinge assembly configured to flex the frame to
selectively change a size of the opening; and a first handle
assembly including a lever portion and a blade portion coupled to
the lever portion, the first handle assembly pivotally mounted to
the frame such that the lever portion extends from the proximal
side of the frame and the blade portion extends from the distal
side of the frame, each of the opposing first and second blades
having a proximal end configured for attachment to the blade
portion of the handle assembly and a distal end portion spaced from
the proximal end; wherein in a first collapsed insertion state the
hinge assembly collapses the frame and the first blade contacts the
second blade, and in a second deployed state the hinge assembly
expands the frame and the first blade is spaced apart from the
second blade; and at least one lip coupled to and extending from
the distal side of the frame, the at least one lip configured to
appose the patient when the opposing first and second blades are
inserted into a vaginal canal.
16. A vaginal speculum comprising: a frame that defines a proximal
side and a distal side and an opening within the frame between a
first blade that is attachable to the frame and a second blade that
is attachable to the frame opposite of the first blade, the frame
including a hinge assembly configured to flex the frame to
selectively change a size of the opening; and a first handle
assembly including a lever portion and a blade portion coupled to
the lever portion, the first handle assembly pivotally mounted to
the frame such that the lever portion extends from the proximal
side of the frame and the blade portion extends from the distal
side of the frame, each of the opposing first and second blades
having a proximal end configured for attachment to the blade
portion of the handle assembly and a distal end portion spaced from
the proximal end; wherein in a first collapsed insertion state the
hinge assembly collapses the frame and the first blade contacts the
second blade, and in a second deployed state the hinge assembly
expands the frame and the first blade is spaced apart from the
second blade; a lateral dilator insertable into the opening, the
lateral dilator comprising: a collar including a collar wall
configured to removably couple with the frame; and at least one
blade extending from the collar and including a dilator handle
assembly mounted to the collar that is configured to move distal
end portions of the lateral blades.
Description
BACKGROUND
Gynecological examinations have become established as well-care
procedures that assist in the early detection of cervical
pre-cancerous and cancerous growths. In general, a physician
employs a speculum or similar device to expand and support the
vaginal vault during the gynecological exam, which enables an
unobstructed view of at least the exo-cervical wall.
FIG. 1 is a perspective view of a known speculum as disclosed in
Hayes, U.S. Pat. No. 4,807,600. Speculum 2 is a rigid device that
includes a handle 3 and an arm 4 coupled to the handle 3 about a
hinge 5. A first blade 6 is integrally formed with handle 3 and a
second blade 7 is integrally formed with arm 4. In the orientation
shown in FIG. 1, first blade 6 is a lower blade of the speculum and
second blade 7 is an upper blade. Each of blades 6, 7 include an
inner surface 8 and an outer surface 9, where the outer surfaces 9
are those surfaces oriented to contact tissue of the patient.
Movement of a thumb piece 10 results in moving upper blade 7
relative to lower blade 6 about hinge 5. A locking device 11 is
provided to secure thumb piece 10 in position to maintain a desired
position of blades 6, 7 during the gynecological exam.
For ease of description, operation of prior art speculums in
general is illustrated with specific reference to the speculum of
Hayes. However, other speculum configurations are known, but each
generally includes a handle coupled to a rigid lower blade and a
rigid upper blade. Speculum 2 is commonly provided in stainless
steel for easy cleaning, although other rigid speculums are formed
of plastic materials. During use, blades 6, 7 are brought together
and inserted into the vaginal introitus. Thumb piece 10 is
depressed to separate upper blade 7 from lower blade 6, thus
expanding the walls of the vaginal vault. Locking device 11 is
engaged to secure blades 6, 7 in their desired position. In this
manner, the physician is able to visualize a portion of the cervix
and have access to the endo-cervical canal for examination and/or
the removal of samples/cells.
Although generally effective, operation of prior art speculums can
undesirably apply pressure along the anterior midline of the pubic
symphysis and the apposed internal vaginal walls. In particular,
when the blades 6, 7 are parted, an upward movement of a proximal
portion 12 of upper blade 7 can cause tissue discomfort during the
examination procedure, especially in the sensitive region anterior
to the pubic symphysis. In addition, even after blades 6, 7 are
secured in their desired position, the weight of handle 3, arm 4,
and thumb piece 10 (located outside the vaginal introitus opposite
of blades 6, 7) conspire to cause blades 6, 7 to slide out of the
desired position, thus displacing speculum 2 and requiring
repositioning by the physician often increasing discomfort to the
patient.
Improved speculums that are more comfortable will encourage
patients to regularly schedule and follow through with these useful
gynecological exams.
SUMMARY
One embodiment provides a vaginal speculum including a frame and a
first handle assembly pivotally mounted to the frame. The frame
defines a proximal side, a distal side, an opening within the frame
between a first blade that is attachable to the frame and a second
blade that is attachable to the frame opposite of the first blade,
and a hinge assembly configured to flex the frame to selectively
change a size of the opening. The first handle assembly includes a
lever portion and a blade portion coupled to the lever portion. The
lever portion extends from the proximal side of the frame and the
blade portion extends from the distal side of the frame. Each of
the opposing first and second blades has a proximal end configured
for attachment to the blade portion of the handle assembly and a
distal end portion spaced from the proximal end. When in a first
collapsed insertion state, the hinge assembly collapses the frame
and the first blade contacts the second blade. When in a second
deployed state the hinge assembly expands the frame and the first
blade is spaced apart from the second blade.
Another embodiment provides a vaginal speculum assembly including a
frame, speculum blades attachable to the frame, and a lateral
dilator insertable into the frame. The frame includes a first
segment including a first end and a separate second end, a second
segment including a first end and a separate second end, a first
hinge assembly coupled between the first ends of the first and
second segments, and a second hinge assembly coupled between the
second ends of the first and second segments to form a frame
periphery defining a proximal side opposite a distal side and an
opening within the frame periphery. The speculum blades include a
first speculum blade attachable to the first segment and a second
speculum blade attachable to the second segment. Each of the first
and second speculum blades has a proximal end attachable to the
frame periphery and a distal end portion spaced from the proximal
end. The lateral dilator is configured for insertion through the
opening defined by the frame periphery and includes first and
second opposed lateral blades. The hinge assemblies configure the
first and second segments of the frame to collapse together to
minimize the opening for insertion of the speculum blades into a
vaginal introitus and configure the first and second segments of
the frame to expand apart to maximize the opening to receive the
lateral dilator.
Another embodiment provides a vaginal speculum configured to
illuminate a vaginal vault during a gynecological procedure. The
vaginal speculum includes a frame and first and second blades
attachable to the frame. The frame includes a first segment and a
first blade support coupled to the first segment, a second segment
and a second blade support coupled to the second segment, where the
frame defines an opening between the first and second segments. The
first blade is attachable to the first blade support, and the
second blade is attachable to the second blade support. One of the
blades and blade supports comprises an illumination assembly
configured to provide a source of light.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments are better understood with reference to the following
drawings. The elements of the drawings are not necessarily to scale
relative to each other. Like reference numerals designate
corresponding similar parts.
FIG. 1 is a perspective view of a representative prior art speculum
including a handle and an upper blade movable relative to a lower
blade.
FIG. 2 is an exploded side view of a speculum assembly including a
speculum frame, blades attachable to the speculum frame, and a
lateral dilator insertable through the speculum frame according to
one embodiment.
FIG. 3 is a plan view of a proximal side of the speculum frame
shown in FIG. 2.
FIG. 4A is a side view of a speculum frame according to one
embodiment.
FIG. 4B is an enlarged view of a hinge assembly of the speculum
frame shown in FIG. 4A.
FIG. 5A is a perspective view of one of the speculum blades of the
speculum assembly shown in FIG. 2.
FIG. 5B is a perspective view of distal ends of the speculum blades
when assembled to the speculum frame shown in FIG. 2.
FIG. 5C is a front view of the distal ends of the speculum blades
shown in FIG. 5B.
FIG. 6A is a plan view of a proximal side of the lateral dilator
shown in FIG. 2 illustrating lateral blades of the dilator in an
insertion orientation.
FIG. 6B is a plan view of the lateral dilator shown in FIG. 6A
illustrating the lateral blades in a deployed orientation.
FIG. 7 is a top view of the speculum assembly shown in FIG. 2 when
assembled.
FIG. 8 is a side view of a speculum frame including a pair of
handle assemblies according to another embodiment.
FIG. 9A is a plan view of a proximal side of a speculum frame
including a flexible tubular frame and a coiled spring enclosed in
the tubular frame according to another embodiment.
FIG. 9B is a plan view of the flexible tubular frame shown in FIG.
9A collapsed into an insertion state.
FIG. 9C is a side view of the collapsed flexible tubular frame
shown in FIG. 9B illustrating a pair of opposing handle
assemblies.
FIG. 10A is a plan view of a proximal side of a speculum frame
including a pair of spring-loaded clip hinge assemblies each
coupled between opposing arcuate segments of the speculum frame
according to another embodiment.
FIG. 10B is a side view and FIGS. 10C-10D are front views of one
spring-loaded clip hinge assembly shown in FIG. 10A.
FIG. 11A is a plan view of a proximal side of a speculum frame
including a rigid tubular frame housing a pair of opposing frame
springs according to another embodiment.
FIG. 11B is a side view of the speculum frame shown in FIG.
11A.
FIGS. 12A-12C are side views of the speculum shown in FIG. 8
illustrating a first collapsed insertion state and a second
expanded deployed state according to one embodiment.
FIGS. 13A-B are perspective views of a lateral dilator according to
another embodiment of the present disclosure.
FIGS. 13C-D are front views of the lateral dilator shown in FIGS.
13A-B.
FIG. 14A is an exploded side view of an illuminated speculum
including an expandable/collapsible speculum frame and blades
attachable to the speculum frame according to one embodiment.
FIG. 14B is a side view of an illuminated blade support of the
illuminated speculum shown in FIG. 14A.
FIG. 15 is a cross-sectional view of a speculum blade attachable to
a speculum frame, where the speculum blade is distally weighted and
includes an illumination assembly according to one embodiment.
FIG. 16A is an exploded side view of an illuminated speculum
assembly including a speculum and a light assembly configured to
couple with the speculum according to another embodiment.
FIG. 16B is a top view of the illuminated speculum assembly shown
in FIG. 16A illustrating the light assembly inserted into a frame
of the speculum.
DETAILED DESCRIPTION
In the following Detailed Description, reference is made to the
accompanying drawings which form a part hereof, and in which is
shown by way of illustration specific embodiments in which the
invention may be practiced. In this regard, directional
terminology, such as "top," "bottom," "front," "back," "leading,"
"trailing," etc., is used with reference to the orientation of the
Figure(s) being described. Because components of the embodiments
can be positioned in a number of different orientations, the
directional terminology is used for purposes of illustration only
and is in no way limiting. As employed in this application, the
singular forms "a," "an," and "the" include the singular and the
plural referents unless the context clearly dictates otherwise.
Thus, for example, "a material" includes the specific material and
other materials.
It is to be understood that other embodiments may be utilized and
structural or logical changes may be made without departing from
the scope of the present invention. The following detailed
description, therefore, is not to be taken in a limiting sense, and
the scope of the invention is defined by the claims.
Embodiments described below provide an expandable/collapsible
"weight forward" vaginal speculum. As employed herein, the term
"weight forward" means a vaginal speculum having a weight
distribution that is configured to be heavier on the side of the
speculum frame to which blades are attached. In other words, the
portion of the vaginal speculum frame including the blades is
heavier than the portion of the vaginal speculum frame including a
handle assembly. The speculum assembly includes a collapsible frame
having a first collapsed insertion state and a second expanded
deployed state. The speculum assembly includes a hinge assembly
that expands/collapses the frame and speculum blades that are
configured to collapse together to enable comfortable insertion
into the vaginal introitus, and expand apart to support walls of
the vagina to enable access to the cervix during a gynecological
procedure. When in the expanded state, the frame and the speculum
blades are configured to minimize pressure along the anterior
midline of the pubic symphysis, which thereby minimizes the
discomfort often associated with gynecological procedures.
In one embodiment, the speculum assembly includes a speculum frame
and blades attachable to the speculum frame, where the speculum
frame is configured to flex/collapse for insertion into a vaginal
introitus and configured to flex/expand to provide a visualization
pathway to the cervix. The speculum frame includes a hinge assembly
that enables the frame to flex and be collapsible and expandable to
change a size/shape between collapsed and expanded states. In a
collapsed insertion state, the speculum frame collapses along a
hinge line to bring the speculum blades together in a manner suited
for insertion into the vaginal introitus. Upon insertion, the frame
is expanded to a second deployed state in which the speculum blades
move apart to support top/bottom walls of the vagina and provide an
opening suited for gynecological examination of the cervical
region.
The speculum frame can be disposable or aseptically reusable. The
speculum blades are attachable and detachable to the speculum frame
and are preferably disposable. Other embodiments provide a lateral
dilator insertable and connectible to the speculum frame that
provides support to apposed side walls of the vagina.
Distal ends of the opposing first and second speculum blades
selectively diverge to support walls of the vagina without
increasing a distance between proximal ends of the speculum blades.
In one embodiment, the proximal ends of the speculum blades
minimally diverge as the distal ends of the speculum blades are
diverged. In another embodiment, the proximal ends of the speculum
blades do not diverge as the distal ends of the speculum blades are
diverged. In this manner, an improved gynecological visualization
channel can be formed without undesirably increasing pressure in
the region of the anterior public symphysis of the patient.
Embodiments described below provide a weight-forward speculum that
is more comfortable to use and is configured to resist slipping out
of the inserted position during the gynecological exam.
FIG. 2 is an exploded side view of a vaginal speculum assembly 20
according to one embodiment. Speculum assembly 20 includes a
speculum 22, top/bottom speculum blades 24a, 24b, respectively,
attachable to speculum 22, and a lateral dilator 26 insertable into
speculum 22 that includes lateral blades 28 and a pair of
attachment clips 29.
Speculum 22 generally includes a frame 30 including a first segment
32 and a second segment 34 that combine to define a proximal side
36 and a distal side 38, a handle assembly 40 coupled to frame 30,
a hinge assembly 42 coupled between first segment 32 and second
segment 34, and a trigger 44. Frame 30 is configured to collapse
(i.e., configured to enable first segment 32 to move/fold or
otherwise advance toward second segment 34) to provide comfortable
insertion of speculum blades 24a, 24b during initiation of a
gynecological procedure and thereafter expand to provide viewing
access to the vaginal vault. Trigger 44 provides a grasping point
along second segment 34 that is suited for gripping with a finger
or thumb, which enables a clinician to collapse frame 30. In one
embodiment, a flexible housing portion of frame 30 is integrally
formed about hinge assembly 42 to minimize the risk of pinching the
patient's skin and in a manner that enables first segment 32 to
move relative to second segment 34 about hinge assembly 42.
Handle assembly 40 generally includes a lever portion 50 coupled to
frame 30 on proximal side 36, and a blade portion 52 coupled to
frame 30 on distal side 38. In one embodiment, handle assembly 40
is pivotally mounted to frame 30 such that movement of lever
portion 50 deflects blade portion 52 up/down relative to the
orientation shown in FIG. 2. A handle retention mechanism 60 is
provided to selectively retain blade portion 52 in a desired
position. In one embodiment, handle retention mechanism 60 includes
a guide 62 and a retainer 64 movable along guide 62 that is
configured to selectively "lock" lever portion 50 and blade portion
52. For example, lever portion 50 is moved a selected distance to
raise/lower blade portion 52 to a desired position, and retainer 64
is locked against lever portion 50 along guide 62 to selectively
lock lever portion (and thus blade portion 52) in the desired
position.
Hinge assembly 42 is coupled between first segment 32 and second
segment 34 of frame 30 and is configured to enable frame 30 to flex
in a manner that moves speculum blades 24a, 24b together/apart
relative to each other. Hinge assembly 42 generally enables frame
30 to be flexible (i.e., collapsible/expandable) and can include a
pair of opposing hinge assemblies 42a, 42b as described below.
In one embodiment, frame 30 optionally includes a first lip 102 and
a second lip 104 that are configured to appose a patient during a
gynecological procedure to ensure that sensitive skin areas are not
unduly irrigated by instruments or manipulation of frame 30. In
another embodiment, protective lips are instead provided on each of
blades 24a, 24b.
Blades 24a 24b are configured to removably couple with blade
portions 52 on distal side 38 of speculum 22. In one embodiment,
blade portions 52 each provide a spring-loaded socket connector 70
configured to removably couple with a socket 72 formed in a
proximal end of the corresponding blade 24a, 24b. Blades 24a, 24b
are preferably disposable, single-use blades that are attachable to
a reusable and aseptically cleanable frame 30. When blades 24a, 24b
are attached to speculum 22, movement of lever portion 50 will
displace distal end portions of blades 24a, 24b away from each
other in a manner configured to expand the walls of the vaginal
vault. Frame 30 and handle assembly 40 are configured to move
distal end portions of blades 24a, 24b apart without increasing a
distance between proximal ends of blades 24a, 24b, as described in
detail below.
FIG. 3 is a plan view of proximal side 36 of speculum 22. In one
embodiment, first segment 32 defines an arcuate segment extending
between a first end 80 and a second end 82, and second segment 34
defines an arcuate segment extending between a first end 90 and a
second end 92. In one embodiment, one or more depressions 74 are
formed in one or both of segments 32, 34 to provide a grasping area
for the clinician's fingers. A first hinge assembly 42a is coupled
between respective first ends 80, 90 of first and second segments
32, 34 to define a first hinge line 94, and a second hinge assembly
42b is coupled between respective second ends 82, 92 of first and
second segments 32, 34 to define a second hinge line 96. Arcuate
segments 32, 34 combine to define an opening 100 within a periphery
of frame 30. Frame 30 of speculum 22 flexes along hinge lines 94,
96 to change a size of opening 100.
In one embodiment, a first lip 102 is coupled to first segment 32,
and a second lip 104 is coupled to second segment 34, where lips
102, 104 extend toward distal side 38 (as best illustrated in FIG.
2) of speculum 22. Lips 102, 104 are configured to appose a patient
during a gynecological procedure to ensure that sensitive skin
areas are not unduly irrigated by instruments or manipulation of
frame 30.
Hinge assemblies 42a, 42b configure frame 30 to flex such that
first segment 32 is collapsible toward second segment 34 to
minimize opening 100 for insertion of blades 24a, 24b into the
vaginal introitus during a gynecological procedure. After
insertion, hinge assemblies 42a, 42b configure frame 30 to expand
such that first section 32 moves away from second section 34 to
maximize opening 100 for access to the vaginal vault and the
cervical region.
In one embodiment, a frame retention mechanism 110 is coupled
between sections 32, 34 of frame 30 to selectively maintain frame
30 in a desired expanded state. Frame retention mechanism 110
includes a first flange 111 coupled to first section 32 of frame 30
and a second flange 113 coupled to second section 34 of frame 30, a
threaded guide 112 extending between flanges 111, 113, and lock
nuts 114 coupled to and movable along guide 112. In one embodiment,
guide 112 is fixed to second flange 113 and movable through a slot
in first flange 111. In general, hinge assemblies 42a, 42b combine
to move segments 32, 34 apart, and lock nuts 114 are provided to
selectively limit an amount of separation between segments 32, 34.
For example, when the desired opening 100 is established between
first section 32 and second section 34, an upper one of the lock
nuts 114 is threaded/moved down guide 112 to seat against flange
111 and selectively maintain a distance between first section 32
and second section 34. A lower one of the lock nuts 114 is provided
to ensure that opening 100 is maintained during the procedure.
Other forms of retention mechanisms are also acceptable. In one
embodiment, frame retention mechanism 110 includes a ratchet rod
having detents that are configured to ratchet relative to an
engagement edge of the first flange 111. Frame 30 is formed of
suitable materials configured to enable first and second sections
32, 34 to flex relative to hinge lines 94, 96. Examples of suitable
materials for frame 30 include braided stainless steel that is
configured to enclose and flex laterally relative to hinge
assemblies 42a, 42b, a flexible frame 30 formed of a polymer or a
polymer blend or a co-polymer, and a frame 30 having rigid sections
32, 34 that bend along hinge lines 94, 96 (such that lips 102, 104
bend in/out of the plane of the page in FIG. 3, for example). In
one embodiment, first and second sections 32, 34 of frame 30 are
molded from polymer such as a high density polyethylene and
attached to hinge assemblies 42a, 42b. Other suitable materials for
frame 30 are also acceptable.
FIG. 4A is a side view of speculum 22 showing a relative location
of hinge assembly 42b, and FIG. 4B is an enlarged view of hinge
assembly 42b. In one embodiment, hinge assembly 42b includes a leaf
spring mechanism having a first band 120 that is coupled to first
section 32 of frame 30, a second band 122 that is coupled to second
section 34 of frame 30, where second band 122 is movably coupled to
first band 120 along a joint 124. In one embodiment, bands 120, 122
are metal bands that flex/deform and recover relative to joint 124.
In one embodiment, joint 124 is a pinned coupling between bands
120, 122. When first section 32 is displaced and collapsed towards
second section 34, hinge assembly 42b deforms along joint 124 and
frame 30 flexes/flattens into an oval or substantially flat shape
such that opening 100 (FIG. 3) is minimized.
During initial insertion of speculum 22, and with reference to FIG.
3, first and second sections 32, 34 of speculum 22 are collapsed
together by the clinician using one or both hands. For example,
speculum 22 is suited for grasping by one hand where fingers are
aligned along first section 32 and the thumb is placed along second
section 34, where the thumb and fingers brought together to
compress speculum 22 into a flat (or substantially oval) shape.
Hinge assemblies 42a, 42b are configured to enable first section 32
to collapse toward second section 34, and are also configured to
provide an expansion force to subsequently first section 32 away
from second section 34 when speculum 22 is inserted into the
vaginal introitus. To this end, hinge assemblies 42a, 42b are
configured to have an appropriate spring constant k that enables an
average clinician to compress speculum 22 in a one-handed manner,
and yet have enough spring force to recover and expand speculum 22
after blades 24a, 24b are inserted into the vaginal introitus.
In one embodiment, hinge assemblies 42a, 42b are compressible and
include a spring constant k of less than about 10.8 pounds per
inch. This relatively low spring constant k is selected as being
the lowest pinch force value for all subjects based on the average
performance of all subjects (male and female, left and right
handed) when tested in a tip pinch challenge employing a B&L
pinch gauge, available from B&L Engineering, Tustin, Calif. (as
reported in Grip and Pinch Strength: Normative Data for Adults,
Mathiowetz et al., ARCH PHYS MED Rehabil 66: 69-72, 1985). For
example, left handed female subjects applied a pinch force of about
10.8 pounds when challenged by the B&L pinch gauge. Thus, in
one embodiment the spring constant k of hinge assembly 42 is
selected to accommodate the pinch force that left handed female
clinicians are able to apply to speculum 22.
In one embodiment, spring constant k for hinge assemblies 42a, 42b
is selected to be slightly higher than the average subject pinch
strength for all left handed female subjects (having the lowest
pinch strength), such that a suitable spring constant k is between
about 10-25 pounds per inch. In this manner, although the spring
constant k is slightly higher than the mean pinch strength for the
weakest clinicians, the spring constant for the force of the hinge
assembly 42a, 42b is selected to provide a relatively larger
recovery force, which is suited to optimally expand speculum 22
after being inserted the vaginal introitus.
Suitable springs for hinge assembly 42 include wound wire springs,
clip springs, leaf springs, coiled springs, flat springs, and the
like. In one embodiment, springs employed in hinge assemblies, 42a,
42b are plastic springs. In other embodiments, springs employed in
the hinge assemblies 42a, 42b are metal springs. One suitable hinge
assembly 42 includes a metal torsion spring available from
Associated Spring, Hartford, Conn. Other suitable springs for hinge
assembly 42 include coiled springs, compression springs, and/or
conical springs available from MW Industries, Logansport, Ind.
FIG. 5A is a perspective view of speculum blade 24a shown in FIG.
2, where the second opposing blade 24b is substantially similar.
Blade 24a includes an exterior surface 130 configured for patient
contact opposite an interior surface 132, a proximal end portion
134 extending between a proximal end 136 and a central portion 138,
and a distal end portion 140 extending between a distal end 142 and
central portion 138. Socket 72 is formed in proximal end portion
134 and is sized to receive blade portion 52 (FIG. 2) of handle
assembly 40. In one embodiment, blade 24a extends along a
longitudinal central axis A and distal end portion 140 includes a
retention lip 150 that curves away from longitudinal axis A in an
upward direction (relative to the orientation of FIG. 5A).
Retention lip 150 is configured to support a portion of the vaginal
vault in providing improved visualization of the cervix and
adjacent vaginal walls during a gynecological procedure.
In one embodiment, blade 24a is configured for single use only and
is disposable. In another embodiment, blade 24a is reusable and
formed of a material suited for repeated use and cleaning, such as
stainless steel, or includes a soft aseptically cleanable polymer
such as silicone.
In one embodiment, exterior surface 130 defines a generally convex
shape including pads 152 that are integrally formed to be soft,
resilient, and flexible and configured to distribute pressure
evenly across sensitive tissue when employed in a gynecological
procedure. In another embodiment, blade 24a is a rigid blade formed
to define socket 72 and receive a separate cover as described in
co-pending U.S. utility patent application Ser. No. 11/728,755
entitled SPECULUM BLADE COVER, which is incorporated into this
disclosure in its entirety. In one embodiment, blades 24a removably
couple with blade portion 52 (FIG. 2) of handle assembly 40. In one
embodiment, a lip 154 is provided along proximal end 136 to
minimize the possibility of pinching the patient's skin between
blade 24 and frame 30.
FIG. 5B is a perspective view of distal ends 142a, 142b of speculum
blades 24a, 24b, respectively, as they would appear when assembled
on speculum 22 (FIG. 2), and FIG. 5C is a front view of distal ends
142a, 142b. Distal ends 142a, 142b are configured to provide
improved retention of blades 24a, 24b within the vaginal vault and
a wider, unimpeded view of the cervical area. The exposed exterior
surfaces 130a, 130b are convex and the interior surfaces 132a, 132b
are curved to provide an opening between the apposed blades 24a,
24b, thus providing improved visual and physical access to the
cervix. In one embodiment, proximal end portions 134a, 134b are
smoothly curved to define another embodiment of a protective lip in
which the lip is gently radiussed to prevent undesirable pinching
of sensitive skin between speculum 22 and blades 24a, 24b.
FIG. 6A is a plan view of a proximal side of lateral dilator 26
illustrating lateral blades 28a, 28b collapsed together in an
insertion orientation, while FIG. 6B illustrates a similar view
showing lateral blades 28a, 28b expanded in a deployed
orientation.
Lateral dilator 26 includes a collar 160, first and second opposed
lateral blades 28a, 28b coupled to and extending from collar 160,
and a dilator handle assembly 166 pivotally mounted to collar 160.
Operation of dilator handle assembly 166 moves lateral blades 28a,
28b laterally left/right relative to collar 160. Lateral dilator 26
is preferably reusable and is formed of a material suited for
aseptic cleaning between procedures, such as stainless steel. In
one embodiment, lateral dilator 26 is injection molded from a
suitable polymer such as polyethylene, polypropylene, polyester, or
other polymers.
In one embodiment, collar 160 includes a collar wall 170 that is
configured to removably couple with frame 30 (FIG. 2) and be held
in place by attachment clips 29. Mechanisms other than the
leaf-spring form of clips 29 for coupling collar 160 to frame 30
are also acceptable, and include pins, snaps, etc. In one
embodiment, collar 160 is a rigid collar and an outer peripheral
edge of collar wall 170 is sized to snap-fit against an inner edge
of frame 30 (FIG. 3). Other suitable forms of coupling collar 160
to frame 30 are also acceptable, such a pinning and/or clipping
collar 160 to the proximal side 36 of frame 30.
Each of the lateral blades 28a, 28b define a rigid elongated
lateral blade that extends from collar 160 by about 3-4 inches and
includes a splayed section 172 adjacent a distal end portion 174.
In one embodiment, dilator handle assembly 166 includes a first
lever 180 coupled to first lateral blade 28a and a second lever 182
coupled to second lateral, blade 28b. First lever 180 and second
lever 182 are coupled to collar 160 about a pivot point 184 such as
a hinge pin. FIG. 6A illustrates dilator handle assembly 166 in an
insertion position in which first and second levers 180, 182 are
separated and distal end portions 172 of lateral blades 28a, 28b
are closed together in an orientation suited for insertion of
dilator 26 into opening 100 of frame 30 (FIG. 3).
FIG. 6B illustrates dilator handle assembly 166 in a deployed
position in which first and second levers 180, 182 have been
squeezed together to move distal end portions 172 of lateral blades
28a, 28b laterally apart and beyond the circumference defined by
collar 160. Dilator 26 is illustrated apart from speculum 22 (FIG.
3) for clarity of illustration, but it is to be understood that
dilator blades 28a, 28b are spread apart after first being inserted
through opening 100 of frame 30 after speculum 22 has been
inserted. After inserting dilator 26 into the opening 100 and
securing attachment clips 29 to frame 30, squeezing first and
second levers 180, 182 together moves blades 28a, 28b outward
relative to collar 160 and rotates distal end portions 172 of
lateral blades 28a, 28b out to their deployed position. In one
embodiment, a ratcheting retention mechanism 186 extending between
first and second levers 180, 182 is provided to selectively retain
levers 180, 182 in a desired deployed position. In this manner,
distal end portions 172 of lateral blades 28a, 28b can be
selectively diverged to support lateral walls of the vaginal vault
as speculum blades 24 (FIG. 2) support top/bottom walls of the
vaginal vault.
FIG. 7 is a top view of the vaginal speculum assembly 20 shown in
FIG. 2 as assembled. Lateral dilator 26 has been inserted into
opening 100 and collar 160 has been coupled to frame 30. Speculum
blades 24 are movable up and down (in and out of the paper as
illustrated in FIG. 7), and lateral blades 28a, 28b are movable
laterally (left and right as oriented in FIG. 7).
During a gynecological procedure, frame 30 is compressed to
collapse opening 100 and bring speculum blades 24 together until
blades 24 touch (or nearly touch). The speculum blades 24 attached
to collapsed frame 30 are inserted into the vaginal introitus until
lips 102, 104 protectively appose the patient. When compression
force applied to the hinge assembly 42 is relieved by the physician
releasing his/her grip on frame 30, frame 30 expands and speculum
blades 24 move apart to support top/bottom walls of the vaginal
vault. Speculum blades 24 may be further diverged, or optimally
positioned according to physician preference, by movement of handle
assembly 40 to suitably size opening 100 for the gynecological
procedure.
After insertion of speculum 22, lateral blades 28a, 28b of dilator
26 are inserted into opening 100 and collar 160 is coupled to frame
30. Levers 180, 182 of handle assembly 166 (FIG. 6A) are squeezed
and lateral blades 28a, 28b are diverged one apart from the other
to support lateral walls of the vaginal vault. In one embodiment,
the lateral blades 28a, 28b of dilator 26 are removable blades
similar to blades 24a, 24b employed by speculum 22 (FIG. 2) and are
configured to couple to blade portions on collar 160 that are
similar to blade portion 52 of frame 30 (FIG. 2).
Frame 30 and handle assembly 40 are configured to diverge the
distal end portions 140 (FIG. 5) of speculum blades 24 without
increasing a distance between proximal ends 136 of blades 24. To
this end, the pressure applied to the anterior midline of the pubic
symphysis is minimized and the procedure is more comfortable for
the patient. In a similar manner, distal end portions 174 of
lateral blades 28a, 28b are configured to diverge apart without
moving proximal ends of lateral blades beyond collar 160 or frame
30. Most of the weight of speculum 22 is distributed on the distal
side 38 of frame 30 when speculum 22 is positioned as described
above. That is to say, blades 24 and frame 30 contribute to a
majority of the weight of speculum 22, such that speculum 22
provides a "weight forward" vaginal speculum. This weight forward
orientation is unchanged when blades 28 of dilator 26 are inserted
into frame 30.
Embodiments described herein provide an expandable/collapsible
"weight forward" vaginal speculum assembly including a speculum
frame and blades attachable to the speculum frame, where the
speculum frame is configured to collapse for insertion into a
vaginal introitus and configured to expand to provide a
visualization pathway to the cervix. Other embodiments of a
speculum frame configured to be collapsible and expandable to
change states, apart from that embodiment described above, are also
within the scope of this application and are described below.
FIG. 8 is a side view of another embodiment of a vaginal speculum
200 including a pair of handle assemblies 212, 214 each suitable
for coupling to one of the removable blades 24 (FIGS. 2 and 5).
Speculum 200 includes a frame 202 having a first section 204, a
second section 206 coupled to first section 204 to define a distal
side 208 opposite a proximal side 210, a first handle assembly 212
coupled to first section 204, and a second handle assembly 214
coupled to second section 206.
In one embodiment, first section 204 is similar to first section 32
(FIGS. 2 and 3) and defines an arcuate section having a lip 220
extending from first section 204. Second section 206 is similar to
second section 34 described above and includes a lip 222 extending
from second section 206. Lips 220, 222 are configured to appose the
patient and minimize the risk that sensitive skin is pinched or
irritated during the gynecological procedure.
In one embodiment, first section 204 and second section 206 are
coupled together by a pair of hinge assemblies 230 similar to the
hinge assemblies 42 described above in FIGS. 2 through 4B to define
an access opening (not shown). Hinge assembly 230 is configured to
enable first section 204 to be collapsed toward second section 206
to compress speculum 200 to a size and shape that is suitably
minimized for insertion of the speculum 200 into the vaginal
introitus.
It is to be understood that speculum 200 is usefully employed with
a pair of speculum blades, such as speculum blades 24 (FIG. 5).
Speculum 200 is configured to be collapsed such that blades 24 are
brought together to touch one another for insertion into the
vaginal introitus. After insertion of the collapsed speculum 200,
hinge assembly 230 expands first section 204 apart from second
section 206 to provide a pathway to the patient's cervix. First
handle assembly 212 is configured to move a first one of the blades
24, and second handle assembly 214 is configured to move a second
one of the blades 24 independent of the first blade, to more
optimally provide access to the cervix during the gynecological
procedure.
In one embodiment, first handle assembly 212 includes a lever
portion 240, a blade portion 242 coupled to lever portion 240, a
pin 244 that pivotally mounts handle assembly 212 to first section
204, and a handle retention mechanism 246 configured to retain
blade portion 242 in a selected deployed position.
In one embodiment, lever portion 240 defines an oblong lever suited
for manipulation by a thumb or finger of a clinician. Lever portion
240 is mechanically coupled to blade portion 242 such that when
lever portion 240 is moved, blade portion 242 moves up/down
(relative to the orientation of FIG. 8) to move an attached
speculum blade 24 up/down. Lever portion 240 is manipulated to
position a distal end portion of speculum blade 24 to a desired
location, and retention mechanism 246 is deployed to maintain
speculum blade 24 in the desired position. Handle retention
mechanism 246 includes a guide 248 fixed to and extending from
first section 204 through a slot in lever portion 240, and a lock
249 configured to secure lever portion 240 relative to guide 248,
in a manner similar to handle retention mechanism 60 (FIG. 2). It
is believed that with experience, the clinician will become adept
at adjusting and locking lever portion 240 in a one-handed
manner.
Speculum 200 includes a second handle assembly 214 including a
second lever portion 250, a second blade portion 252 coupled to
lever portion 250, and a pin 254 that pivotally couples handle
assembly 214 to second section 206 of speculum 200. In one
embodiment, lever portion 250 extends away from proximal side 210
of frame 202 and blade portion 252 extends from distal side 208. In
one embodiment, second handle assembly 214 includes a retention
mechanism 256 configured to maintain a position of lever portion
250 relative to second section 206. For example, retention
mechanism 256 is similar to retention mechanism 246 and includes a
guide 258 extending from second section 206 through a slot in lever
portion 250, and a lock 259 configured to selectively retain lever
portion 250 relative to guide 258.
First handle assembly 212 and second handle assembly 214 are each
configured to independently move a speculum blade 24 coupled to one
of the blade portions 242, 252. Lever portion 250 is movable to
position a distal end portion 140 of the first speculum blade 24
coupled to blade portion 242 to a desired location, and second
lever portion 250 is movable to position the second speculum blade
24 in a desired position. Each of first blade portion 242 and
second blade portion 252 include a spring loaded socket retainer
270 configured to removably couple with socket 72 (FIG. 2) formed
in speculum blades 24.
In one embodiment, speculum 200 includes a frame retention
mechanism 280 that is similar to frame retention mechanism 110
(FIG. 3), and likewise includes a nut 284 coupled to a guide 286
that combine to maintain a desired relative position between first
section 204 and second section 206 when speculum 200 is in an
inserted position. In general, frame 202, including blades 24, is
collapsed to an insertion state in which first section 204 and
second section 206 are brought together until blades 24 contact one
another (or nearly contact one another), speculum 200 is inserted
into the vaginal introitus, and hinge assembly 230 expands first
section 204 away from second section 206. Frame retention mechanism
280 is employed to maintain a selected distance between first and
second sections 204, 206; Handle assemblies 212, 214 are deflected
to move a distal end portion of blades 24 apart to support and
retract the vaginal walls. When a desired positioning of distal end
portions of blades 24 is achieved, handle retention mechanisms 246,
256, respectively, are secured to hold blades 24 in position.
FIGS. 9A and 9B are plan views of a proximal side of a speculum 300
including a flexible frame 302 according to another embodiment.
Speculum 300 includes speculum frame 302 having a first section 304
and a second section 306, a first handle assembly 308 coupled to
first section 304, a second handle assembly 310 coupled to second
section 306, a first hinge assembly 312a coupled between opposing
ends of first and second section 304, 306, and a second hinge
assembly 312b coupled between a second set of opposing ends of
first and second sections 304, 306.
In one embodiment, frame 302 includes a flexible rubber housing 314
disposed over an exterior surface of a coiled spring 320. In one
embodiment, coiled spring 320 includes a first coiled spring 322
extending through first section 304 between hinge assemblies 312a,
312b, and a second spring 324 extending through second section 306
between hinge assemblies 312a, 312b. In another embodiment, springs
322 and 324 combine to define a single continuous coiled spring 320
extending within a periphery of flexible housing 314, and separate
hinge assembly lines 312a, 312b are formed in flexible housing 314
to define a part line for frame 302.
Housing 314 is flexible to enable first section 304 to collapse
toward second section 306. In one embodiment, housing 314 is formed
of a polymer tubing and frame 302 flattens when collapsed and
forces hinge assembly 312a to the left, for example, and hinge
assembly 312b to the right away from first hinge assembly 312a (as
oriented in FIG. 9A and shown in FIG. 9B).
The view illustrated in FIGS. 9A and 9B is oriented toward the
proximal side of speculum 300. FIG. 9C is a side view of speculum
300 showing blade portions 328, 330, respectively, extending from
handle assemblies 308, 310. For clarity, the detachable mechanisms
are omitted from the drawings. The blade portions 328, 330 are each
configured to receive a speculum blade 24 (FIG. 2), and are each
configured to independently move distal end portions of the
attached blade 24 in a manner that is similar to the function of
handle assemblies 212, 214 (FIG. 8).
When flexible housing 314 is collapsed, spring 320 flexes to enable
frame 302 to flatten, reducing opening 340, and configure blades 24
for insertion into the patient during the gynecological procedure,
and this orientation is illustrated in FIG. 9B. Spring 320 and
hinge assemblies 312a, 312b configure speculum 300 to expand and
recover to a substantially circular shape providing an expanded
opening 340 (FIG. 9A).
Suitable springs 320 include coiled springs available from MW
Industries, Logansport, Ind. Other suitable springs, such as
torsion springs, compression springs, conical springs, are also
acceptable.
FIG. 10A is a plan view of a proximal side of a vaginal speculum
400 according to another embodiment. Speculum 400 includes a frame
402 having a first section 404, a second section 406, a first
handle assembly 408 coupled to first section 404, a second handle
assembly 410 coupled to second section 406, and hinge assemblies
412a, 412b coupled between first section 404 and second section
406. A flexible sheath 413 is provided to protectively enclose
hinge assemblies 412a, 412b, where the flexible sheath 413 flexes
and moves as hinge assemblies 412a, 412b adjust a shape of frame
402. In one embodiment, flexible sheath is formed of an
autoclavable silicone, although other suitable flexible materials
are also acceptable. Hinge assemblies 412a, 412b include
spring-loaded clips that flex laterally when a thumb piece 470 is
deployed by the clinician to selectively collapse/expand first
section 404 relative to second section 406.
In one embodiment, first section 404 includes a first end 420
spaced from a second end 422, and second section 406 includes a
first end 430 spaced from a separate second end 432. First hinge
assembly 412a is coupled between first ends 420, 430 of sections
404, 406, respectively, and second hinge assembly 412b is coupled
between second ends 422, 432 of first and second sections 404, 406,
respectively.
FIG. 10B is a side view and FIGS. 10C-10D are front views of hinge
assembly 412a. With reference to FIG. 10B, in one embodiment hinge
assembly 412a includes a base 440 defining a passage 442, a spring
444 insertable into passage 442, and a follower 446 coupled to
spring 444. In general, base 440 is coupled to one of the ends 420,
430 of frame 402. In one embodiment, spring 444 is a compressed
coil spring including a first end 450 coupled to a base of passage
442 and a second end 452 coupled to follower 446. In one
embodiment, follower 446 includes a first end 460 configured to
couple with thumb piece 470 (FIG. 10A) and a second end 462 coupled
to spring 444. Hinge assembly 412a is configured to move between a
substantially rigid state in which spring 444 and second end 462 of
follower 446 are stowed in passage 442, and a flexed/open state in
which follower 446 and spring 444 extend/expand out of passage 442.
In this regard, hinge assembly 412 is similar to a climber's
carabiner that is deployable between a fixed/clipped state and an
open state.
Speculum 400 includes a first collapsed insertion state in which
hinge assembly 412 collapses frame 402 and blades 24 contact (or
nearly contact) one another, and a second deployed state in which
hinge assembly 412 expands frame 402 and blades 24 are spread
apart. In the first collapsed insertion state, follower 446 and
spring 444 extend/expand out of passage 442 to enable first section
404 to bend/collapse toward second section 406. In the second
deployed state, follower 446 and spring 444 are stowed in passage
442 and hinge assembly 412 supports first section 404 apart from
second section 406. To this end, follower 446 is compressible into
passage 442 to expand the periphery of frame 402. In the deployed
state, sections 404, 406 are aligned in a planar fashion (shown in
FIG. 10B) to provide a substantially circular periphery of frame
402 and define an opening 480 in speculum 400 (shown in FIG.
10A).
FIG. 11A is a plan view of a proximal side of a vaginal speculum
500 according to another embodiment. Speculum 500 includes a
substantially rigid frame 502 that is compressible up/down as
oriented in FIG. 11A. Frame 502 includes a first section 504, a
second section 506 insertable into a portion of first section 504,
and a handle assembly 508 coupled to first section 504. In one
embodiment, first section 504 defines a generally U-shaped section
including a base 510, a first leg 512 extending from base 510, and
a second leg 514 extending from base 510 and spaced apart from
first leg 512. In one embodiment, second section 506 is also a
generally U-shaped section including a base 520, a first leg
extending from base 520, and a second leg 524 extending from base
520 and separated from first leg 522. In general, legs 512, 514 of
first section 504 are tubular legs configured to receive tubular
legs 522, 524 of second section 506, with a first spring 530 is
disposed within tubular legs 512, 522, and a second spring 540 is
disposed within tubular legs 514, 524. Springs 530, 540 bias
sections 504, 506 away from each other and enable rigid frame 502
to collapse for insertion during a gynecological procedure.
When speculum 500 is so assembled, first section 504 is
spring-loaded relative to second section 506, and a compressive
force applied to first section 504 will compress first section 504
toward second section 506 by compressing springs 530, 540. In this
manner, speculum 500 is configured to be compressed to a minimum
size suitable for insertion of blades (not shown) into a vaginal
introitus during a gynecological examination. After insertion,
springs 530, 540 provide a recovery force that pushes first section
504 away from second section 506 to define an opening 550 within
frame 502 of speculum 500. A frame retention mechanism 580, similar
to frame retention mechanism 110 (FIG. 3), is provided to maintain
a selected distance between biased portions 510, 520 of first
section 504 and second section 506.
FIG. 11B is a side view of speculum 500. In one embodiment, handle
assembly 508 includes a lever portion 560 and a blade portion 562,
where handle assembly 508 is pivotally mounted to first section 504
about an axis 564. In general, movement of lever portion 560
downward translates to an upward movement of blade portion 562. In
one embodiment, blade portion 562 is movable through a range from a
substantially horizontal position to an angle C of about 45 degrees
from the horizontal position. In this manner, movement or toggling
lever portion 560 downward translates to an upward movement of
blade portion 562 in the range of up to about 45 degrees. Lever
portion 560 is similar to lever portions described above, and blade
portion 562 is similar to the blade portions described above. In
particular, blade portion 562 is configured to removably receive in
socket-like fashion speculum blade 24 (FIG. 2).
Operation of speculum 200 and blades 24 is described with reference
to FIGS. 12A-12C. FIGS. 12A-12C are side views of the speculum
shown in FIG. 8 illustrating a first collapsed insertion state
(FIG. 12A) and a second expanded deployed state (FIGS. 12B-12C)
according to one embodiment. Referring to FIGS. 8A and 12A, during
a gynecological procedure, the clinician compresses first section
204 toward second section 206 to collapse blades 24 together into a
first collapsed insertion state. It is to be understood that blades
24 are configured to be collapsed together and contact one another,
but for ease of illustration blades 24 are shown spaced slightly
apart to better show the relationship between first and second
sections 204, 206. When collapsed, guide rod 286 extends upward
beyond first section 204 and blades 24 touch (or nearly touch) and
are suited for insertion into the vaginal introitus to assist in
the gynecological procedure.
FIG. 12B is a side view of speculum 200 showing hinge assembly 230
expanding first section 204 apart from second section 206 such that
speculum 200 occupies a deployed state in which an opening (not
visible) is formed between first and second sections 204, 206.
Blades 24 are positioned within the vaginal vault to support and
part apposed walls of the vagina to provide access to an exterior
wall of the cervix. In one embodiment, a cinch device in the form
of nuts 284a, 284b is provided. Other forms of cinch device 284a,
284b are also acceptable. Nuts 284a, 284b are threaded along guide
rod 286 until fastened against an upper flange 291 to selectively
maintain sections 204, 206 in a desired deployed position. In
general, nut 284a limits expansion of frame 202 and nut 284b
provides a "stop" that limits collapse of frame 202 during a
procedure.
FIG. 12C is a side view of speculum 200 in the second deployed
state after lever portions 240, 250 have been moved to selectively
diverge distal end portions of speculum blades 24. The clinician
manipulates lever portions 240, 250 to diverge the distal end
portions of speculum blades 24. In one embodiment, speculum blades
24 pivot and diverge up to about 45 degrees from the horizontal.
When speculum blades 24 are positioned in the desired location,
locks 249, 259 are secured against lever portion 240, 250,
respectively, to lock handle assemblies 212, 214 in the desired
deployed position. In one embodiment, movement of first lever
portion 240 moves the distal end portion of first blade 24 apart,
and movement of second lever portion 250 independently moves the
other distal end portion of second blade 24 apart to diverge and
support apposed walls of the vagina without increasing a distance
between proximal ends 136 of blades 24. In one contrasting
embodiment, when blades 24 are coupled to vaginal speculum assembly
20 illustrated in FIG. 2, the lower blade 24 does not move relative
to frame 30. Upper blade 24 (FIG. 2) moves in response to movement
of handle assembly 40.
FIGS. 13A and 13B are perspective views of a lateral dilator 600
according to another embodiment. Dilator 600 is configured to
couple to the speculum frames described above and includes a
dilator handle assembly 602 and a blade assembly 604 coupled to
dilator handle assembly 602. In one embodiment, dilator handle
assembly 602 includes a first collar 606 and a second collar 608
that is rotatably coupled to first collar 606. Dilator 600 is
configured such that movement of collar 608 relative to collar 606
selectively expands and contracts a distal end 610 of blade
assembly 604. For example, FIG. 13A illustrates collar 608 in
neutral alignment with collar 606 and distal end 610 of blade
assembly 604 in a neutral state having a diameter D1, such that
dilator 600 is configured for insertion into the opening of the
above-referenced speculum frames. FIG. 13B illustrates collar 608
rotated relative to collar 606 such that distal end 610 is expanded
to a diameter D2 that is greater than diameter D1.
In one embodiment, collar 606 includes pins 612a, 612b that are
configured to coupled collar 606 to a frame of speculum 22,
speculum 200, speculum 300, speculum 400, or speculum 500 described
above. Other mechanisms configured for coupling collar 606 to a
frame of a speculum are also acceptable.
In one embodiment, blade assembly 604 includes a sheet of material
wrapped in cylindrical form and coupled to dilator handle assembly
602. In one embodiment, blade assembly 604 is formed from
transparent material configured to transmit light. For example,
lighted speculums are known in the art that accommodate a light
that is useful in illuminating the speculum blades during a
gynecological procedure. Dilator 600 is configured to be employed
with these lighted speculums, and blade assembly 604 is formed of a
transparent material that is configured to transmit the light
emitted by the lighted speculum. In one embodiment, blade assembly
604 is fabricated from polyester, polyethylenenaphthlate, or other
suitable polymer material, or one or more layers of these suitable
polymer materials.
FIGS. 13C and 13D illustrate front views of dilator 600. In one
embodiment, dilator 600 includes a brace 620 coupled between
dilator handle assembly 602 and distal end 610 of blade assembly
604, where brace 620 is configured to couple with a groove 622
formed in an interior surface of blade assembly 604. In one
embodiment, movement of collar 608 (FIGS. 13A-13B) moves brace 620
within groove 622 and changes the diameter of distal end 610 of
lateral dilator 600.
FIG. 13C illustrates brace 620 when distal end 610 of blade
assembly 604 is in a first state having a diameter D1 that is
suited for insertion into a frame of one of the speculums described
above.
FIG. 13D illustrates distal end 610 of blade assembly 604 in an
expanded state having diameter D2 that is larger than diameter D1,
such that lateral dilator 600 is suited for providing an improved
visualization pathway to the cervix during a gynecological
procedure. In one embodiment, D2 is larger than D1, for example D2
is between about 1.25D1 to about 2.25D1, preferably D2 is about
1.5D1 such that D2 expands to about 50% larger than D1.
FIG. 14A is an exploded side view of an illuminated speculum 700
according to one embodiment. Speculum 700 includes a frame 702
including a first segment 704 and a second segment 706, a blade
support 708 coupled to first segment 704 that is configured to
receive a blade 710, and a blade support 712 coupled to second
segment 706 that is configured to receive blade 714. In one
embodiment, frame 702 is similar to frame 30 described above in
FIG. 2 and includes a hinge assembly 720 configured to collapse
first segment 704 toward second segment 706, a frame retention
mechanism 722 configured to selectively maintain first segment 704
positioned relative to second segment 706, and a handle assembly
724 including a handle 726 that is coupled to blade support
708.
In one embodiment, blade support 708 includes a socket connector
730 that is configured to couple with socket 732 of blade 710 to
removably retain blade 710 relative to frame 702, and blade support
712 includes a socket connector 740 that is configured to couple
with socket 742 of blade 714 to removably retain blade 714 on blade
support 712. In one embodiment, blade support 712 and socket
connector 740 are configured such that a light source is activated
when blade 714 is coupled to support 712, as described below.
In one embodiment, blade support 708 is movable and blade support
712 is fixed. For example, in one embodiment movement of handle 726
moves blade support 708 up and down relative to the orientation of
FIG. 14 such that blade 710, when coupled to blade support 708,
likewise moves up and down. The selective movement of blade 710
contributes to improved access and visualization of the cervical
area during a gynecological procedure.
FIG. 14B is a side view of an illuminated blade support 712. In one
embodiment, blade support 712 is fixed relative to frame 702 and
includes an illumination assembly 750 including a light source 752
and an energy source 754. In one embodiment, illumination assembly
750 is disposed adjacent to a distal end portion 756 of blade
support 712 such that speculum 700 is weight-biased to provide a
weight forward speculum 700. In one embodiment, energy source 754
is provided separately from blade support 712, for example within
frame 702 (FIG. 14A), or alternatively, exterior to speculum 700.
Illumination assembly 750 is contained within blade support 712.
When blade 714 is engaged over blade support 712, illumination
assembly 750 is protected from possible cross-contamination
associated with the use of speculum 700 in a clinical setting
having multiple patients/procedures. In one embodiment, blade 714
is a single use blade and light source 752 is reusable. In
combination, disposable blade 714 is configured to minimize the
potential for undesirable cross-contamination of reusable light
source 752 when speculum 700 is employed with more than one
patient.
In one embodiment, light source 752 is a light-emitting diode and
energy source 754 is a battery. Other forms of light source 752 and
energy source 754 are also acceptable, including Xenon or
incandescent bulbs and lithium ion batteries. In one embodiment,
illumination assembly 750 is removably coupled to blade support
712, for example by a threaded attachment represented by line 760.
In one embodiment, illumination assembly 750 is integrally formed
in distal end portion 756 of blade support 712. In one embodiment,
illumination assembly 750 is provided apart from blade support 712
and light is delivered to distal end portion 756 by fiber optic
means such as fiber optic stands and/or cables. For example, in one
embodiment light source 752 is disposed on frame 702 and light is
transmitted along blade support 712 via a fiber optic
component.
In one embodiment, blade 714 is configured to enable light
generated by light source 752 to transmit through at least a
portion of blade 714. For example, in one embodiment at least one
surface 770 of blade 714 is fabricated of transparent material and
is configured to enable light to shine on the region between blades
710, 714. Suitable transparent materials for surface 770 include
silicones, such as clear silicones, polyacrylates, methacrylates,
polycarbonates, blends and co-polymers of these materials and other
optically clear polymeric materials.
FIGS. 14A and 14B provides one exemplary embodiment of an
expandable and collapsible vaginal speculum frame including a
weight forward illumination assembly. During use, blades 710, 714
are coupled to respective blade supports 708, 712 and speculum 700
is inserted into the vaginal introitus as described above.
Illumination assembly 750 is activated to provide light 772 that
emanates from light source 752 through surface 770 of blade 714. In
this manner, speculum 700 provides improved illumination of the
cervical region, even in patients having a prolapsed vaginal vault
or in bariatric patients.
FIG. 15 is a cross-sectional view of an illuminated speculum blade
800 according to one embodiment. Illuminated speculum blade 800
includes an exterior surface 802 configured for patient contact
opposite an interior surface 804, a proximal end portion 806
extending between a proximal end 808 and a central portion 810, a
distal end portion 812 extending between a distal end 814 and
central portion 810, and an illumination assembly 816. In one
embodiment, illuminated speculum blade 800 is configured to provide
a speculum to which it is attached with a forward-biased weight
distribution. To this end, one embodiment of blade 800 optionally
includes an additional weight 818 disposed in proximal end portion
812.
In one embodiment, proximal end 808 defines a socket 820 that is
configured to couple with a blade portion of a speculum frame, such
as blade portion 52 described above in FIG. 2.
In one embodiment, illumination assembly 816 includes a light
source 830, an energy source 832, and control circuitry 834
disposed within speculum blade 800. In one embodiment, illumination
assembly 816 optionally includes wiring 836 extending from light
source 830 to proximal end 808 that is suited for coupling to an
external power source. In one embodiment, illumination assembly 816
is provided apart from speculum blade 800 and configured to deliver
light to distal end portion 812, which is configured to permit the
light to pass therethrough. In one embodiment, light source 830
and/or energy source 832 is/are provided separately from speculum
blade 800, for example within the speculum frame to which blade 800
attaches, or alternatively, exterior to the speculum frame.
In one embodiment, light source 830 includes a light-emitting
diode, energy source 832 includes one or more batteries, and
control circuitry 834 is configured to selectively activate light
source 830 between on and off positions. In one embodiment, control
circuitry 832 is configured to sense when blade portion 52 (FIG. 2)
is inserted into socket 820, subsequently illuminating light source
830 when blade 800 is assembled to speculum frame 30, for
example.
In one embodiment, interior surface 804 is formed of a transparent
material and configured to enable light 840 emitted from light
source 830 to be transmitted through interior surface 804. In one
embodiment, a body portion 850 of blade 800 includes a transparent
polymeric material that is molded around illumination assembly 816
and configured to enable the passage of light. Suitable transparent
materials for body portion 850 include silicones, such as clear
silicones, polyacrylates, methacrylates, polycarbonates, blends and
co-polymers of these materials and other optically clear polymeric
materials.
FIG. 15 provides an exemplary embodiment of an illuminated speculum
blade that is configured to be removably attached to a speculum
frame. The illuminated speculum blade provides illumination
adjacent to a distal end portion of the blade (and thus the
speculum), which provides light for improved illumination of the
cervical region, even in patients having a prolapsed vaginal vault
or in bariatric patients.
FIG. 16A is an exploded side view of an illuminated speculum
assembly 900 according to another embodiment. Speculum assembly 900
includes a speculum 902 and a removable light assembly 904 that is
insertable into speculum 902. Illuminated speculum assembly 900 is
configured to provide improved visualization of the vaginal vault
in the region of the cervix through a light source that is suited
for repeated use while minimizing the potential for
cross-contamination between patients.
In one embodiment, speculum 902 includes a frame 905 including a
first segment 906 and a second segment 908, a blade support 910
coupled to first segment 906 that is configured to receive a blade
similar to blade 710 (FIG. 14A), and a blade support 914 coupled to
second segment 908 that is shown coupled to a blade 916.
In one embodiment, frame 905 is similar to frame 30 (FIG. 2) and
includes a hinge assembly 920 configured to collapse first segment
906 toward second segment 908, a frame retention mechanism 922
configured to selectively maintain first segment 906 relative to
second segment 908, a handle assembly 924 including a handle 926
that is coupled to blade support 910, and a passageway 928 that
communicates with blades support 914.
In one embodiment, blade support 910 includes connectors 930 and a
weight 932a. Connectors 930 are configured to couple into a socket
similar to the socket 732 defined by blade 710 (FIG. 14A) to
removably retain the blade relative to frame 905. Weight 932a is
disposed at a distal end portion 934 of blade support 910, and thus
configured to provide speculum 902 with a weight-forward
construction that resists sliding or displacement when inserted
into the vaginal vault.
In one embodiment, weight 932a is a solid mass of metal configured
to transfer a balance point of speculum 902 toward its distal end
portion. In one embodiment, blade support 914 defines a light pipe
940, a weight 932b similar to weight 932a, and connectors 942 that
are configured to couple with and removably retain blade 916. In
one embodiment, light pipe 940 defines a hollow segment that is
configured to transmit light from light assembly 904 toward distal
end portion 944 of blade support 914. In one embodiment, the hollow
segment defined by light pipe 940 includes a surface that is
configured to enable light to pass along its length. Suitable
material for forming light pipe 940 includes, mirrored surfaces or
optical film such as 3M brand Optical Lighting Film, available from
3M Company, St. Paul, Minn. In one embodiment, blade 916 is a
single-use disposable blade that is configured to transmit light
through at least a distal end portion 944 of blade support 914. For
example, in one embodiment blade 916 includes an optically clear
side 936 and an optically opaque side 938. Optically clear side 936
is generally provided on the side of blade 916 that is oriented
towards the vaginal vault/cervix, and opaque side 938 is generally
oriented toward the vaginal wall. In this manner, light emitted
from light assembly 904 is incident upon the cervix.
In one embodiment, light assembly 904 includes a light source 950
and a cover 952. In one embodiment, light source 950 is a
self-contained light emitting diode (LED) light source that is
activated (e.g., "turned on") and inserted into passageway 928
defined by frame 905. Light source 950 includes the LED and an
energy source for powering the LED and is configured to emit light
that travels along light pipe 940 toward distal end portion 944 of
blade support 914. In one embodiment, light is selective emitted
from one side of distal end portion 944, for example the side
oriented in the direction between blade supports 910, 914. In
another embodiment, light is emitted radially from distal end
portion 944 of blade support 914.
In another embodiment, light source 950 is inserted into passageway
928 and covered by cover 952, and light source 950 illuminates in
response to blade 916 coupling with blade support 914.
FIG. 16B is a top view of the illuminated speculum assembly 900
shown in FIG. 16A illustrating light source 950 inserted into frame
905 of speculum 902. Cover 952 is provided to minimize
contamination of light source 952 during a gynecological
examination. In one embodiment, cover 952 is a rigid cover that
provides a housing for light source 950 and a handle configured to
assist in manipulating light source 950. One exemplary embodiment
of cover 952 is configured to activate light source 950 when cover
952 is snapped or positioned over light source 950 and/or coupled
to frame 905. Suitable materials for forming cover 952 include
polymer materials, such as polyethylene or other polyolefins,
polyester, or nylon.
In another embodiment, cover 952 is a thin-film aseptic drape
configured to provide a clean and/or aseptic field over light
source 950. In general, cover 952 is configured to minimize the
potential for contamination and cross-contamination of the reusable
light source 950 during gynecological procedures. In one
embodiment, cover 952 includes a thin-film formed as a plastic
drape having a thickness of between about 0.0005 to 0.050 inches
having adhesive applied to one surface that is configured to attach
drape/cover 952 to light source 950. Suitable materials for
drape/cover 952 include plastic films in general and polyethylene
films and block co-polymer films in particular.
During use, and with reference to FIGS. 16A-16B, blade 916 is
coupled to blade support 914 and light source 950 is inserted into
passageway 928. Light source 950 is either activated prior to
insertion into passageway 928, or light source 950 is activated
when cover 952 is placed over light source 950 and coupled to frame
905. Light from light source 950 travels along light pipe 940
defined by blade support 914, passes through optically clear side
936 of blade 916, and is incident on the cervix. Cover 952 prevents
or minimizes the possibility of contamination of light source 950
by biological material. Light source 950 and frame 905 are
reusable, and cover 952 and blade 916 are disposable to provide an
illuminated speculum assembly 900 that provides improved
visualization of the vaginal vault and cervix while minimizing the
potential for cross-contamination of biological material between
patients.
Although specific embodiments have been illustrated and described
herein, it will be appreciated by those of ordinary skill in the
art that a variety of alternate and/or equivalent implementations
may be substituted for the specific embodiments shown and described
without departing from the scope of the present invention. This
application is intended to cover any adaptations or variations of
the specific embodiments discussed herein. Therefore, it is
intended that this invention be limited only by the claims and the
equivalents thereof.
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